MAUDE Adverse Event Report: VIANT MEDICAL, LLC OFFSET REAMER HANDLE

Model Number 255000100

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The ifu sent with this device today, man-004006 rev a, states the following; end of life is determined by wear and damage due to intended use.Visually inspect for damage and wear.If the instrument is damaged and worn it is considered at the end of its life and should be discarded.Where instruments form part of a larger assembly, check assembly with mating components.Viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures.Do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion.Manual surgical instruments have a limited life-span which is determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device has experienced approximately 0.97 years of use.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field.In conclusion, the complaint sample was not received by viant for evaluation and the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated, the complaint record will be updated accordingly, and a supplemental medwatch 3500a emdr will be submitted as well.No further investigation is required at this time.Report source: complaint information provided by distributor, depuy synthes.

Event Description

It was reported during an unknown procedure on a 58 year old male patient that the offset reamer handle has significant circular wobble when connected to power, causing uneven, non-hemispherical reaming of the acetabulum.There was no significant delay.No known consequences or impact to patient.

• Brand Name: OFFSET REAMER HANDLE
• Type of Device: REAMER HANDLE
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818
• MDR Report Key: 16414269
• MDR Text Key: 310056220
• Report Number: 3004976965-2023-00002
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000100
• Device Catalogue Number: T17653
• Device Lot Number: PC5319141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male